Non-pharmacological Methods for the Control of Anxiety and Pain During Outpatient Hysteroscopy (Metodiche Non Farmacologiche Per il Controllo di Ansia e Dolore Durante Isteroscopia Ambulatoriale)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 3
- 主要终点
- post-hysteroscopic pain, evaluated using a 1-10 Numeric Rating Scale (NRS)
研究概览
简要总结
The administration of pharmacological and non-pharmacological aids during in-office hysteroscopic surgery is often used to both relieve the patient from discomfort and facilitate the operator in performing the procedure. The investigators aim to test the hypothesis that watching a video clip or listening to music would act as non-pharmacological relief for reducing anxiety and pain during in-office hysteroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal and postmenopausal women
- •Indication for in-office operative hysteroscopy
排除标准
- •Denied consent
- •Use of analgesic drugs before the procedure
研究组 & 干预措施
Vocal-Local
干预措施: In-Office Hysteroscopy (Procedure)
Video
干预措施: In-Office Hysteroscopy (Procedure)
Music
干预措施: In-Office Hysteroscopy (Procedure)
结局指标
主要结局
post-hysteroscopic pain, evaluated using a 1-10 Numeric Rating Scale (NRS)
时间窗: 24 hours
1 (better) - 10 (worse)
The anxiety, evaluated by means of State-Trait Anxiety Inventory (STAI) questionaries
时间窗: 24 hours
20 (better) - 80 (worse)
次要结局
未报告次要终点
研究者
Gaetano Riemma
Principal Investigator
University of Campania Luigi Vanvitelli